Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)

NCT00802737 | Completed Phase 4 Results

• 2 other identifiers: 111827GEN416
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the trial is to investigate the efficacy and safety of ofatumumab retreatment and maintenance in patients with chronic lymphocytic leukemia who have previously responded or had disease stabilization after ofatumumab in an ongoing trial (Hx-CD20-406).

Conditions

Leukaemia, Lymphocytic, Chronic

Keywords

Maintenance; Retreatment; Chronic lymphocytic leukemia; B-Cell Chronic Lymphocytic Leukemia; Ofatumumab

Outcome Measures

Primary Outcomes (1)

• Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines

  Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) on 2 consecutive visits \>=56 days apart were classified as Rs; those with stable disease (SD)/progressive disease (PD) were classified as NRs. Per the NCIWG 1996 guidelines: CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, normocellular bone marrow sample for age, \<30% lymphocytes (LC), no lymphoid nodule; PR: \>=50% decrease in LC/lymphadenopathy; nPR: persistent bone marrow nodules; PD: new lesion or increase by \>=50% from baseline; SD: no CR, PR, or PD.

  Start of treatment (Week 0/Visit 2) until Week 52

Secondary Outcomes (12)

• Duration of Response

  From the time of the initial response until progression or death (average of 14.1 study months)

• Progression-Free Survival (PFS)

  Start of treatment (Week 0 of Visit 2) until progression or death (average of 14.1 study months)

• Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment

  Time from start of study treatment (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (average of 14.8 study months)

• Overall Survival (OS)

  Time from start of study treatment (Week 0 of Visit 2) until date of death or time that participant was no longer followed (median of 18.0 months)

• Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 4

  Baseline (Visit 2) and Month 4

Study Arms (1)

Ofatumumab

EXPERIMENTAL

Eight once weekly infusions (1 x 300 mg + 7 x 2000 mg), then 2000 mg once monthly for two years

Drug: Ofatumumab

Interventions

Ofatumumab DRUG

Eight once weekly infusions (1 x 300 mg + 7 x 2000 mg), then 2000 mg once monthly for two years

Also known as: HuMax-CD20

Ofatumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has responded to ofatumumab treatment (CR, nPR, PR) or has had SD at least up to and including visit number 14 (24 weeks after first infusion) in the Hx-CD20-406 trial.
• Has disease progression after visit number 14 (24 weeks after first infusion) in the Hx CD20 406 trial.
• Received at least eight ofatumumab infusions.
• Has active CLL with an indication for treatment.
• Has Eastern Cooperative Oncology Group (ECOG) performance status grade 0, 1 or 2.
• Provides signed informed consent, following receipt of verbal and written information about the trial, before any trial related activity is carried out.
• If previously treated in GEN416 (this trial), the patient must have achieved CR with subsequent disease progression 24 weeks or later after the first infusion in the GEN416 trial.

You may not qualify if:

• The disease has transformed to more aggressive B-cell malignancies (e.g. diffuse large B-cell lymphoma, Richter's syndrome or prolymphocytic leukemia).
• Has a suspected treatment requiring malignancy other than CLL.
• Has received treatment other than ofatumumab within two weeks prior to visit 2.
• Has clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from visit 1, congestive heart failure (NYHA III IV), and arrhythmia requiring therapy, with the exception of clinically non-significant extra systoles or minor conduction abnormalities.
• Has significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
• Has a history of significant cerebrovascular disease.
• Is known HIV positive.
• Has positive serology for hepatitis B, defined as a positive test for HBsAg and/or positive tests for both anti-HBs and anti-HBc.
• Has known or suspected hypersensitivity to components of the IMP.
• Has received treatment with any non-marketed drug substance or experimental therapy other than ofatumumab within four weeks prior to visit 2.
• Currently participates in any other interventional clinical trial other than Hx-CD20-406.
• Known or suspected to not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychiatric disorder).
• Is breast feeding (women only).
• Has a positive pregnancy test at screening (women only).
• Is not willing to use adequate contraception during the trial and one year after last dose of ofatumumab (women only). Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the US the use of double barrier method is considered adequate.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Genmab: collaborator

Study Sites (2)

GSK Investigational Site

Örebro, SE-701 85, Sweden

Location

GSK Investigational Site

Stockholm, SE-171 76, Sweden

Location

Related Publications (1)

• van Oers MH, Kuliczkowski K, Smolej L, Petrini M, Offner F, Grosicki S, Levin MD, Gupta I, Phillips J, Williams V, Manson S, Lisby S, Geisler C; PROLONG study investigators. Ofatumumab maintenance versus observation in relapsed chronic lymphocytic leukaemia (PROLONG): an open-label, multicentre, randomised phase 3 study. Lancet Oncol. 2015 Oct;16(13):1370-9. doi: 10.1016/S1470-2045(15)00143-6. Epub 2015 Sep 13.

  PMID: 26377300 DERIVED

MeSH Terms

Conditions

Leukemia, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: January 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: May 1, 2013
• Last Updated: May 14, 2014
• Results First Posted: June 26, 2012

Record last verified: 2014-04

Locations

SE (2)